Local Application of Autologous Bone Marrow Cells for Tre... | NCT00292357

Studies
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers

NCT00292357

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jan 18, 2010Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Diabetic Foot
Diabetes Complications

Interventions

Application of autologous bone marrow

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2010

Last Update Posted Date

Jan 18, 2010Estimated

Description Module

Brief Summary

Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Application of autologous bone marrow	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus
chronic non-healing foot ulcers (>4weeks)

Exclusion Criteria:

Charcot foot
Non-diabetic ulcers
Ulcers healing under conventional therapy
Sepsis
Hematologic disorders
Pregnancy
Acute inflammatory disorders
Chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Per Humpert, MD	Contact	+49 6221 56	8787	per.humpert@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Peter Nawroth, MD	University of Heidelberg, Dept. Medicine 1, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik 1, Universitätsklinikum Heidelberg	Recruiting	Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D048909	Diabetes Complications

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Safety and Feasibility
Healing velocity